Cellectis, a biopharmaceutical company focused on developing immunotherapies based on gene edited CAR T-cells (UCART), announced that it entered into a new agreement for the cGMP manufacturing of UCART123 clinical batches, Cellectis' lead product candidate, with CELLforCURE, a contract manufacturing organization and part of the biopharmaceutical company LFB,  which has an industrial facility for clinical and commercial production of cell therapies in Europe.

CELLforCURE will be in charge of implementing cGMP manufacturing processes designed and developed by Cellectis. Following the recent successful production of UCART19, pursuant to this second agreement CELLforCURE will be responsible for the manufacturing of cGMP clinical batches for UCART123, the lead engineered T-cell product candidate in Cellectis' portfolio. UCART123 targets CD123, an antigen expressed on the surface of cancer cells in malignancies, such as acute myeloid leukemia (AML) and blastic plasmacytoid dendritic cells neoplasm (BPDCN).

UCARTs (Universal Chimeric Antigen Receptor T-cells) are “off-the-shelf” allogeneic product candidates. Their production can be industrialized and standardized with consistent pharmaceutical release criteria, over time and from batch to batch, according to the company.

Peripheral Blood Monoculear Cells from healthy donors are transduced and genetically edited with Cellectis' TALEN technology to seek and destroy cancer cells. This approach could lead to a drug that would be cost-effective, made readily available “off the shelf” – to broad patient populations in hospitals without need for local CAR-T processing facilities and distributed across geographies.

Source: CELLforCURE